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SPIDER: A Research & QI Collaboration Supporting Practices in Improving Care for Complex Elderly Patients (SPIDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689049
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2018
Last Update Posted : December 1, 2023
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
North York General Hospital
College of Family Physicians of Canada
University of Ottawa
University of Alberta
University of Calgary
University of Manitoba
Research Manitoba
Fonds de la Recherche en Santé du Québec
Université de Montréal
Nova Scotia Health Authority
Dalhousie University
Dalhousie Medical Research Foundation
Doctors Nova Scotia
Memorial University of Newfoundland
University of British Columbia
Information provided by (Responsible Party):
University of Toronto Practice Based Research Network

Study Description
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Brief Summary:
Elders living with multiple chronic conditions often take many drugs (polypharmacy); some of the drugs may not benefit them or may be harmful. The Canadian Institute for Health Information has reported that about one-quarter of Canadian seniors are prescribed ten or more different drugs each year. Polypharmacy can result in poorer health, reduced quality of life and high healthcare costs. Choosing Wisely Canada and the Canadian Deprescribing Network have suggested wiser uses for the following four Potentially Inappropriate Prescriptions (PIPs): drugs that reduce stomach acid; reduce anxiety and induce sleep; treat agitation; and treat type 2 diabetes but have a high risk of low blood sugar. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Using quality improvement (QI) and supported by Electronic Medical Record (EMR) data, SPIDER will invite family doctors, nurses, pharmacists and front desk staff to participate in Learning Collaboratives and learn from each other. The practice teams will work with a QI Coach to identify areas to improve, develop strategies and implement changes tailored to the local practice context. The objective of this study is to determine whether SPIDER will reduce PIPs for patients 65 years or older who are on ten or more different drugs. The study will also explore patient experience and provider satisfaction with SPIDER and assess the cost of running SPIDER. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a Randomized Controlled Trial (RCT) in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.

Condition or disease Intervention/treatment Phase
Polypharmacy Inappropriate Prescribing Aged Primary Health Care Quality Improvement Electronic Health Records Procedure: SPIDER Procedure: Usual Care Not Applicable

Detailed Description:
Polypharmacy is pervasive amongst elderly patients living with multiple chronic conditions and the prevalence is increasing. The Canadian Institute for Health Information recently reported that 26.5% Canadian seniors were prescribed ten or more different drugs in 2016. A member of our team (S. Dahrouge) has found that number of prescription proved to be the most reliable index of persistent complexity and high cost in patients 65 years or older. There is also an association between number of prescription and potentially inappropriate prescriptions (PIPs). Analyses conducted on 86 practices affiliated with the University of Toronto Practice Based Research Network (UTOPIAN) have found that family physicians look after a mean of 24 older patients prescribed ten or more medications each year. Polypharmacy in the elderly is associated with elevated risks of adverse drug reactions, frailty and falls. It also increases healthcare, drug, and hospitalization costs. While several medications can be problematic, the following four classes of PIPs have been specifically identified by Choosing Wisely Canada and the Canadian Deprescribing Network as targets for wiser uses in elders: proton pump inhibitors (PPIs), sedative hypnotics such as benzodiazepines, antipsychotics for agitation and medications with a higher risk of hypoglycemia such as long-acting sulfonylureas. To improve care for elderly patients living with polypharmacy, we propose SPIDER: a Structured Process Informed by Data, Evidence and Research. Leveraging existing Quality Improvement (QI) capacity and provision of validated EMR data, SPIDER will engage inter-professional practice teams. They will participate in Learning Collaboratives and work with QI Coaches to identify areas of improvement, develop strategies and implement changes to improve care. The study aims to assess whether SPIDER can reduce PIPs in older patients prescribed ten or more medications. Patient experience, provider satisfaction and cost-effectiveness of SPIDER will also be evaluated. The study will first be tested for feasibility in Toronto, Edmonton and Montreal. Findings will then guide a pragmatic cluster RCT in Calgary, Winnipeg, Ottawa, Montreal and Halifax where practices enrolled in the SPIDER intervention will be compared with those in usual care.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention will first be tested for feasibility using a single-arm, prospective, explanatory mixed approach. What we learn from the feasibility will then be applied to a 2-arm pragmatic cluster RCT where practices enrolled in the intervention group will be compared with those enrolled in the usual care group. Randomization will be at the practice level to avoid potential contamination where physicians practicing at the same location are enrolled in different arms.
Masking: None (Open Label)
Masking Description: Blinding of participants cannot be achieved in pragmatic trials of QI interventions in primary care.
Primary Purpose: Health Services Research
Official Title: SPIDER: A Structured Process Informed by Data, Evidence and Research - A Research and Quality Improvement Collaboration Supporting Practices in Improving Care for Complex Elderly Patients
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: SPIDER
QI Learning Collaboratives.
 Procedure: SPIDER
The SPIDER intervention will include a family physician-led inter-professional practice team participating in 3-4 Learning Collaboratives over a period of 12 months, reviewing validated and comparable practice EMR data and working with a QI Coach to develop strategies and implement changes to improve care for elderly patients living with complex care needs and taking ten or more unique medications.

Procedure: Usual Care
Physicians and their teams enrolled in this arm will follow the best scientific evidence available to provide standard care that is in the best interest of their patients.
Placebo Comparator: Usual Care
Standard primary care.
 Procedure: Usual Care
Physicians and their teams enrolled in this arm will follow the best scientific evidence available to provide standard care that is in the best interest of their patients.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Potentially Inappropriate Prescriptions (PIPs). [ Time Frame: 12 months ]
    The primary outcome is the number of prescribed medications identified as one of the four targeted PIPs recommended by Choosing Wisely Canada and the Canadian DePrescribing Network (CaDeN).


Secondary Outcome Measures :
  1. Patient perception of SPIDER [ Time Frame: 12 months ]
    Qualitative methods (survey and interview) will be used to measure patients' perception of SPIDER. Patients' attitude toward polypharmacy and deprescribing will be measured using a survey adopted from Veterans Affairs Multi-dimensional Survey. Patients' experience with the process, symptoms, relationship with the care provider, empowerment and care coordination dimension will be measured using an interview.

  2. Care provider perception of SPIDER [ Time Frame: 12 months ]
    Qualitative methods (survey and focus group) will be used to measure care providers' perception of SPIDER, including the dimensions of acceptability, implementation, adaptation, integration, practicality and efficacy.

  3. Cost-utility of SPIDER [ Time Frame: 12 months ]
    The cost-utility of SPIDER will be measured as the incremental gain in quality of life (measured by EuroQol-5D) between the two arms in relation to intervention costs and by comparing the differences in investments and healthcare costs captured through EMR data and emergency room use and hospitalization.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. At practice level: a) contributes EMR data to the repository of a Practice Based Research Network (PBRN) that participates in CPCSSN; and b) includes a primary care provider (PCP) who consents to participate and lead the practice QI team.
  2. At PCP level: a) practices comprehensive family medicine in an office setting (academic or non-academic); and b) consents to participate and allow the research staff to provide study information to their eligible patients.
  3. At patient level: a) 65 years or older; b) has at least one office visit during the past 2 years; and c) has received ten or more different prescription medications (as indicated in the EMR) in the past year.

Exclusion criteria:

  1. At practice level: a) Does not use EMR; b) does not contributes EMR data to the repository of a PBRN that participates in CPCSSN; or c) none of the PCPs at the practice consents to participate.
  2. At PCP level: a) does not practice comprehensive family medicine in an office setting; b) does not consent to participate; c) does not allow the research staff to contact or provide study information to their eligible patients; or d) has left the practice.
  3. At patient level: a) younger than 65 years of age; b) has not visited a practice over the past 2 years; or c) has received fewer than ten different prescription medications in the past year.

(Note:

  • PBRN: Practice Based Research Network;
  • CPCSSN: the Canadian Primary Care Sentinel Surveillance Network)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689049


Locations
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Canada, Alberta
Southern Alberta Primary Care Research Network (SAPCReN)
Calgary, Alberta, Canada, T2N 4N1
Northern Alberta Primary Care Research Network (NAPCReN)
Edmonton, Alberta, Canada, T6G 2T4
Canada, British Columbia
British Columbia node of the pan-Canadian CPCSSN (BC-CPCSSN)
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
Manitoba Primary Care Research Network (MaPCReN)
Winnipeg, Manitoba, Canada, R3E 0T6
Canada, Newfoundland and Labrador
Atlantic Practice Based Research Network (APBRN)
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Maritime Family Practice Research Network (MaRNet-FP)
Halifax, Nova Scotia, Canada, B3H 2E2
Canada, Ontario
Ottawa Practice Enhancement Network (OPEN )
Ottawa, Ontario, Canada, K1R 7G5
University of Toronto Practice Based Research Network
Toronto, Ontario, Canada, M5G 1V7
Canada, Quebec
Réseau de recherche en soins primaires de l'Université de Montréal (RRSPUM)
Laval, Quebec, Canada, H7M 3L9
Sponsors and Collaborators
University of Toronto Practice Based Research Network
Canadian Institutes of Health Research (CIHR)
University of Toronto
North York General Hospital
College of Family Physicians of Canada
University of Ottawa
University of Alberta
University of Calgary
University of Manitoba
Research Manitoba
Fonds de la Recherche en Santé du Québec
Université de Montréal
Nova Scotia Health Authority
Dalhousie University
Dalhousie Medical Research Foundation
Doctors Nova Scotia
Memorial University of Newfoundland
University of British Columbia
Investigators
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Principal Investigator: Michelle Greiver, MD North York General Hospital
  Study Documents (Full-Text)

Documents provided by University of Toronto Practice Based Research Network:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] September 4, 2018

More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Udow-Phillips M, Ehrlich E, Kofke-Egger H. Health Care Cost Drivers: Chronic Disease, Comorbidity, and Health Risk Factors in the U.S. and Michigan | Center for Healthcare Research & Transformation. Ann Arbor: Center for Healthcare Research & Transformation 2010.
Moturu S, Johnson W, Liu H. Predictive risk modelling for forecasting high-cost patients: A real-world application using Medicaid data. International Journal Biomedical Engineering and Technology. 2010;3(1-2):114-132.
Wodchis W, Austin P, Newman A, Carollo A, Henry D. The Concentration of Health Care Spending: Little Ado (yet) About Much (money). 2012; https://www.cahspr.ca/en/presentation/5244423937dee8014beea024.
Glazier R, Agha M, Creatore M, Gozdyra P. High Cost Health Care Users: A Focus on Health Links. 2017. http://www.torontohealthprofiles.ca/a_documents/aboutTheData/HealthQualityTablepresentationOnHighUsers.pdf.
The Breakthrough Series: IHI's Collaborative Model for Achieving Breakthrough Improvement. IHI Innovation Series white paper. 2003. http://www.ihi.org/resources/Pages/IHIWhitePapers/TheBreakthroughSeriesIHIsCollaborativeModelforAchievingBreakthroughImprovement.aspx.
Dahrouge S, Wodchis W. Identifying high users in Ontario - an algorithm for use in primary care practices. 2017;In press.
Canadian Deprescribing Network: Deprescribing algorithms. 2017; https://www.deprescribingnetwork.ca/algorithms/.
Donner A. Some aspects of the design and analysis of cluster randomization trials. Appl Stat. 1998;47:95-113.
Romanow R. Building on values: the future of health care in Canada. Ottawa2002.
Clement S. The self-efficacy expectations and occupational preferences of females and males. Journal of Occupational Psychology. 1987;60(3):257-265.
Wodchis W, Bushmeneva K, Nikitović M, McKillop IH, McKillop E. Guidelines on Person-level Costing Using Administrative Databases in Ontario. Working Paper Series. Vol 1. 2013.
WHO Collaborating Centre for drug statistic methodology - ATC/DDD Index. 2017; https://www.whocc.no/atc_ddd_index/.
Greiver M, Martin K, Aliarzadeh B, Lambert-Lanning A, Leggett J. Implementing a scalable tool for quality improvement in primary care: a report for Canada Health Infoway. Toronto December 2013.
Patton M. Qualitative evaluation and research methods. 2nd ed. Newbery Park, CA: Sage Publication; 1990.
Glaser B, Strauss A. The discovery of grounded theory: Strategies for qualitative research. New York: Aldine de Gruyter; 1967.
Strauss A, Corbin J. Basics of qualitative research: Grounded theory procedures and techniques. Newbury Park, CA: Sage; 1990.
UTOPIAN Idea to Proposal Course (I2P). 2016; http://www.dfcm.utoronto.ca/utopian-idea-proposal-course-i2p.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Toronto Practice Based Research Network
ClinicalTrials.gov Identifier: NCT03689049    
Other Study ID Numbers: KPG-156886
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This study uses some data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) for outcome measurement. A data dictionary is available from CPCSSN. While data sharing agreements prohibit CPCSSN from making the data publicly available, access may be granted to those who meet pre-specified criteria for confidential access, available at http://cpcssn.ca/research-resources/cpcssn-data-for-research/; researchers with additional questions can contact CPCSSN by using the link. Outcome data collected for this project can be made available to researchers upon request; a SPIDER study member will need to be part of the new work to ensure adequate interpretation of the data. The study protocol including statistical analysis plan and informed consent form will be publicly available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available within 12 months of study completion
Access Criteria: Outcome data collected for this project can be made available to researchers upon request; a SPIDER study member will need to be part of the new work to ensure adequate interpretation of the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Toronto Practice Based Research Network:
Polypharmacy
Deprescribing
Aged Adult
Elderly Patient
Primary Health Care
 Quality Improvement
Practice Facilitation
Learning Collaborative
Electronic Medical Records (EMR)